1. Field of the Invention
This invention relates to an artificial, non-surgical means of supporting the bladder, the rectum, the bowel, the vagina and/or the uterus of women who have poor vaginal wall support.
2. Description of Related Art
Vaginal support devices have been known to exist for many centuries. The need for such medical prostheses is by no means a recent occurrence. Various appliances have been used over the ages, although they all are meant to achieve the same end. Namely, these devices add to the support of the vaginal wall in order to help prevent prolapse of the uterus and/or bladder and/or the rectum through the vaginal opening.
At the present time, there are various appliances in use. However, there are certain objections that are shared by all of the presently available devices. Among these objections is the fact that a physician has to fit the proper size, as all pessaries are of a fixed size, and, therefore, must be fitted individually according to the patient's needs. Inherent in this rigidly structured system is that if the best size for a given patient were to fall between the sizes that were manufactured, then that patient would be deprived of her optimal size. In addition, most women have difficulty removing and/or replacing the pessary by themselves, and this necessitates repeated doctor visits to remove the pessary, clean or replace it with a new pessary, and then reinsert the pessary. Moreover, because of the constant and prolonged use of an indwelling pessary, a frequent complaint of users of these devices is that vaginal mucus and bacterial build-up creates infection, foul odor and significant secretions, all of which can be unpleasant, annoying and embarrassing. It should be pointed out that many patients requiring a vaginal pessary are elderly, and not infrequently have diminished mobility due to their age and concomitant impairments. indeed, one of the greatest scourges that frequently occurs in older age women is urinary incontinence, which can be a direct result of vaginal prolapse. Often, these women are left to decide between wearing absorptive diapers, or submitting to uncomfortable surgical procedures attended by all of the well-known risks associated with any surgical procedure. Even when the surgical route is selected there is no certainty that it will be successful, although the increasing costs associated with any surgical procedure, not to mention the additional hazards attached to surgery of the elderly, are certainly guaranteed. Moreover as there is an ever increasing number of older women, there is a growing population of patients with this problem.
Another significant obstacle has been that, to obtain an effective device, substantial sacrifices must be made. For example, highly effective devices are typically difficult to manipulate and, therefore, painful to remove and reinsert. This is so because the opening to the vagina is smaller in diameter than the vaginal cavity itself; and it is this difference which is utilized to keep various pessaries from failing out, or being expelled during instances of increased pelvic pressure. Hence, a pessary must be small enough to pass through the vaginal opening, but large enough so that it does not fall out. This requires a pessary that can either change its shape and/or size, or make use of another physical principle, such as surface tension.